| Zoster (shingles) |
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| Disease Issues |
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What is the cause of herpes zoster (shingles)? |
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| Herpes zoster is
a painful rash that occurs along one or more
dermatomes. Zoster is caused by reactivation
of latent varicella zoster virus infection
from a prior
chickenpox infection. People who have had a
prior infection with varicella zoster virus
(chickenpox) are at risk of shingles. |
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| How common is
herpes zoster (shingles)? |
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| During their
lifetime about 30% of Americans will develop
herpes zoster, which translates into an
estimated 1 million cases each year in this
country. The risk of zoster
increases with increasing age; about half of
all cases occur among people age 60 years or
older. People who are immunosuppressed, as
occurs with leukemia,
lymphoma, and human immunodeficiency virus
(HIV) infection, and people who receive
immunosuppressive drugs, such as steroids and
cancer chemotherapy, are also
at greater risk of zoster. People who develop
zoster typically have only one episode in
their lifetime. In rare cases a person can
have a second or third episode. |
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| Can you catch
zoster from a person with active zoster
infection? |
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| Zoster is caused
by reactivation of a latent varicella virus
infection (from having chickenpox in the
past). Zoster is not passed from one person to
another through
exposure to another person with zoster.
However, if a person who is susceptible to
chickenpox (i.e. they had never had chickenpox
and were not vaccinated against
chickenpox) comes in direct contact with a
person with a zoster rash, the virus could be
transmitted to the susceptible person. The exposed person would develop
chickenpox, not zoster. Covering the zoster
rash reduces the chances of transmitting
varicella zoster virus. |
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| For our
"Mother's Day Out" program, one of the
teachers has shingles. The program serves moms
of 2-month-olds to 4-year-olds. All children
are up to date with their
vaccinations, but some are too young to have
received varicella vaccine. Is it safe for the
teacher to work? |
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| In a school
setting, an immunocompetent person with zoster
(staff or students) can remain at school as
long as the lesions can be completely covered.
People with zoster
should be careful about personal hygiene, wash
their hands after touching their lesions, and
avoid close contact with others. If the
lesions cannot be completely covered
and close contact avoided, the person should
be excluded from the school setting until the
zoster lesions have crusted over. See
www.cdc.gov/chickenpox/outbreaks/manual.html
for more information. If your program is
licensed by a state or county, you should
check their regulations as well. |
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| What zoster
vaccines are available in the United States? |
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| Two zoster
vaccines are available in the United States.
Zoster vaccine live (ZVL, Zostavax, Merck) is
a live attenuated vaccine that was licensed in
2006. Although it is
approved by the Food and Drug Administration
(FDA) for persons 50 years and older, the
Advisory Committee on Immunization Practices
(ACIP) recommends ZVL
vaccination for persons 60 years of age and
older. It is administered as a single dose by
the subcutaneous route. |
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| Recombinant
zoster vaccine (RZV, Shingrix,
GlaxoSmithKline) was licensed by the FDA in
October 2017. It is a subunit vaccine that
contains recombinant varicella zoster
virus (VZV) glycoprotein E in combination with
a novel adjuvant (AS01B). RZV does not contain
live VZV. It is approved and recommended by
ACIP for persons 50 years
and older. RZV is administered as a 2-dose
series by the intramuscular route. The second
dose should be given 2 to 6 months after the
first dose. |
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| How effective
are zoster vaccines? |
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| In clinical
trials ZVL recipients had a 51% overall
reduction in shingles and less severe illness
when shingles did occur compared with placebo
recipients. ZVL efficacy
was inversely related to age; efficacy was 70%
among persons 50-59 years of age, 64% among
persons 60-69 years of age and 38% among
persons 70 years and
older. Protection against shingles declined
over time after vaccination. By 6 years after
vaccination protection declined to less than
35%. |
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| RZV was studied
in 2 pre-licensure clinical trials. Efficacy
against shingles was 97% for persons 50–59
years of age, 97% for persons 60–69 years of
age, and 91% for
persons 70 years and older. Among persons 70
years and older vaccine efficacy was 85% 4
years after vaccination. |
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| Will
administering zoster vaccine prevent
postherpetic neuralgia (PHN)? |
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| Both zoster
vaccines reduce the risk of PHN. In the
pre-licensure trial ZVL was 67% effective in
preventing PHN. RZV reduced the risk of PHN by
91%. |
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| To whom should
zoster vaccine be given? |
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| The Advisory
Committee on Immunization Practices (ACIP)
published revised zoster vaccination
recommendations in January 2018 (available at
www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm6703a5-H.pdf). |
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- Recombinant
zoster vaccine (RZV) is recommended for the
prevention of herpes zoster and related complications for immunocompetent adults 50
years of age
and older
- RZV is recommended for the prevention of
herpes zoster and related complications for
immunocompetent adults who previously
received zoster vaccine live
(ZVL)
- ZVL remains a recommended vaccine for
prevention of herpes zoster and its
complications in immunocompetent adults 60
years of age and older. However,
RZV is preferred over ZVL in this age group
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| These
recommendations are a supplement to the 2008
recommendations for the use of ZVL in
immunocompetent adults 60 years of age and
older, available at
www.cdc.gov/mmwr/PDF/rr/rr5705.pdf. |
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| The 2018
zoster vaccine recommendations say that ZVL
remains a "recommended vaccine for prevention
of herpes zoster" in immunocompetent adults
age 60 years and
older. How should providers interpret this language? |
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| While RZV is the
preferred zoster vaccine, ZVL may still be
given to immunocompetent adults aged 60 years
and older in certain cases, such as when RZV
is not
available, or when a person prefers ZVL or is
allergic to RZV. |
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I am having trouble getting RZV (Shingrix) for
my patients. What should I do during the
shortage? |
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| Due to high
levels of demand for RZV, the manufacturer
(GlaxoSmithKline [GSK]) has implemented order
limits and providers have experienced shipping
delays. It is anticipated that order limits
and shipping delays will continue throughout
2019.
Additionally, GSK will continue to release
doses to all customer types on a consistent and predictable schedule during 2019.
(https://www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html#note4). |
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| Clinicians and
patients should make every effort to ensure
that two doses of RZV are administered within
the recommended interval of 2 to 6 months. If
more than 6
months have elapsed since the first dose of
RZV, administer the second dose when possible.
Do not restart the vaccine series, and do not
substitute ZVL (Zostavax) for
the second dose of RZV. If you are out of RZV
and a patient needs a second dose, the Vaccine
Finder may be helpful for patients to locate
other providers that have RZV
in stock. The Vaccine Finder can be accessed
on the CDC website at
www.cdc.gov/vaccines/vpd/shingles/public/shingrix/index.html. |
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| CDC still
recommends ZVL (Zostavax) for healthy adults
60 years and older to prevent shingles. This
shingles vaccine may be used in certain cases,
such as when a
person prefers ZVL or requests vaccination and
RZV is unavailable. Patients who have received ZVL are recommended to subsequently receive
RZV. Age and time since
receipt of ZVL may be considered to determine
when to vaccinate with RZV. The minimum
interval between ZVL and RZV is 8 weeks. |
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| Additional
information for clinicians about RZV is
available on the CDC website at
www.cdc.gov/vaccines/vpd/shingles/hcp/index.html. |
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| I have ZVL in
my freezer but I do not have recombinant
zoster vaccine. The manufacturer told us to anticipate ordering limits and intermittent
shipping delays for RZV so I don’t know when I will get RZV doses. In this situation, what is the
appropriate approach to patients who come to
my practice for shingles vaccine? |
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| It is anticipated
order limits and shipping delays will continue
throughout 2019. ACIP has stated a preference
for RZV for people age 50 years and older.
However, ACIP
also states that ZVL may be used at the
clinician's discretion for people age 60 years
and older. So, if a person age 60 years or
older wants zoster vaccine and RZV is
not available, then use of ZVL is appropriate.
ZVL provides the best protection in the first
year after vaccination. ACIP recommends that
people who receive ZVL should
be revaccinated with a 2-dose series of RZV.
The minimum interval between ZVL and RZV is 8
weeks. Patients should be informed of the
recommendation for RZV after
ZVL if they choose to receive ZVL. |
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| Should RZV be
given to people who have already received ZVL?
If so what interval should separate them? |
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| ACIP recommends
that people who previously received ZVL
receive 2 doses of RZV. The first dose of RZV
should be given at least 2 months after ZVL. |
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| What is the
minimum interval between doses of RZV? |
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| The recommended
interval between RZV doses is 2 to 6 months.
The minimum interval between doses of RZV is 4 weeks. If the second dose is given less than 4
weeks
after the first dose the second dose should be
repeated at least 8 weeks after the invalid
dose. |
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| What is the
minimum age for administering RZV? |
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| The recommended
and minimum age for RZV is 50 years. However,
if a dose is inadvertently administered to an adult 18 through 49 years of age CDC does not
recommend repeating the dose. The second RZV
dose should not be administered until the 50th
birthday. This guidance does not appear in the
most recent zoster ACIP
statement but is in the General Best Practices
Guidance (Table 3-1 in the Timing and Spacing
of Immunobiologics section at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html) and is based on
guidance from CDC’s zoster subject matter
experts. |
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| If the second
dose of RZV is delayed more than 6 months
after the first dose do I need to restart the
series? |
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| No. The vaccine
series need not be restarted if more than 6
months have elapsed since the first dose. |
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| Live zoster
vaccine (ZVL) is approved by the FDA for
people age 50 years and older. Does ACIP
recommend that clinicians vaccinate people in
their 50s with ZVL? |
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| ACIP does not
recommend routine ZVL vaccination of people 50
through 59 years of age. However, ZVL is
approved by the FDA for persons age 50 through
59 years
and clinicians may vaccinate persons in this
age group without an ACIP recommendation.
Notwithstanding FDA’s licensure, ACIP prefers RZV over ZVL. |
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| If I choose to
vaccinate patients age 50–59 years with ZVL,
are there any criteria as to which patients in
this age group might benefit most from this
vaccine? |
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| ACIP recommends
routine vaccination of people 50 years and
older with recombinant zoster vaccine (RZV).
For vaccination providers who choose to use ZVL for
persons 50 through 59 years of age despite the
absence of an ACIP recommendation, factors
that might be considered include particularly
poor anticipated tolerance of
herpes zoster or postherpetic neuralgia
symptoms (for example, attributable to
preexisting chronic pain, severe depression,
or other comorbid conditions; or inability to
tolerate treatment medications because of
hypersensitivity or interactions with other
chronic medications). More information on this
issue is available at
www.cdc.gov/mmwr/pdf/wk/mm6044.pdf, page 1528. |
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| Is there an
upper age limit for receipt of zoster vaccine? |
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| There is no upper
age limit for either zoster vaccine. |
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| If a patient
received dose #1 of varicella vaccine (Varivax,
Merck) at age 60 years, should we administer zoster vaccine as dose #2? |
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| The action taken
depends on why varicella vaccine was given in
the first place. If it was given because the
person tested negative for varicella antibody,
then the next
dose should be varicella vaccine. If the
varicella vaccine was given in error (i.e.,
without serologic testing), then RZV or ZVL
should be given. |
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| Should a
person who received 2 doses of varicella
vaccine be vaccinated with zoster vaccine when
they turn 50? |
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| In its 2018
zoster vaccine recommendations, the Advisory
Committee on Immunization Practices states
that recombinant zoster vaccine (RZV; Shingrix,
GlaxoSmithKline)
may be used in adults age 50 years or older irrespective of prior receipt of varicella
vaccine or live zoster vaccine (ZVL; Zostavax,
Merck). |
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| I understand
that varicella vaccine, MMRV (ProQuad, Merck),
and live zoster vaccine each have different concentrations of virus. Would you tell me how
they are
different? |
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| A dose of
varicella vaccine has 1,350 plaque forming
units (PFUs) of varicella vaccine virus, MMRV
contains 9,800 PFUs (7 times higher than
varicella vaccine), and live
zoster vaccine contains 19,400 PFUs (14 times
higher than varicella vaccine) at the date of
expiration. RZV does not contain live
varicella zoster virus. |
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| Before
administering zoster vaccine is it necessary
to ask if the person has ever had chickenpox
or shingles? |
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| No. All persons
age 50 years or older-whether they have a
history of chickenpox or shingles or
not-should be given RZV unless they have a
medical contraindication to
vaccination (described below). It is also not
necessary to test for varicella antibody prior
to or after giving the vaccine. |
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| Should people
who haven't had chickenpox be vaccinated with
zoster vaccine? |
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| Serologic studies
indicate that almost everyone born in the
United States before 1980 has had chickenpox
even though many cannot recall having had
chickenpox
(
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm.)
As a result, there is no need to ask people
age 50 years and older for their varicella
disease history or to
perform a laboratory test for serologic
evidence of prior varicella disease. A person
age 50 years or older who has no medical
contraindications is eligible for
recombinant zoster vaccine regardless of their
memory of having had chickenpox. |
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| Can someone
who has experienced an episode of shingles be
vaccinated with zoster vaccine? |
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| Yes. Adults with
a history of herpes zoster should receive RZV.
If a person is experiencing an episode of
zoster, vaccination should be delayed until
the acute phase of
the illness is over and symptoms abate. |
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| If a person
was exposed to shingles by a spouse within the
last few days, is there a recommended waiting period before the exposed person can receive
zoster vaccine? |
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| There is no
waiting period in such a situation. Zoster
vaccine can be given right away or at any time
to any person for whom the vaccine is
recommended. Shingles is
not caused by exposure to another person with
shingles. However, exposure to someone with
shingles can possibly cause chickenpox in a
person with no immunity to
varicella zoster virus (VZV) from either
vaccination or prior chickenpox infection.
Zoster is caused by the reactivation of VZV in
people who have already had a prior
VZV infection. |
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| A 33-year-old
patient in my practice has already suffered
from three episodes of shingles. He would like
to receive the zoster vaccine. Is this a good
idea? |
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| ACIP does not
have a recommendation to administer either
zoster vaccine to people younger than 50 years
with recurrent zoster episodes. However,
clinicians may
choose to administer a vaccine off-label, if
in their clinical judgment, they think the
vaccine is indicated. The patient should be
informed that the use is off-label, and that
the safety and efficacy of the vaccine has not
been tested in people younger than 50. |
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| We have an
18-year-old male who had a history of
chickenpox disease. He now has shingles. We
are unsure what we are to advise for future
treatment. Should we
administer zoster vaccine? |
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| The Advisory
Committee on Immunization Practice does not
recommend zoster vaccination for people
younger than age 50 years regardless of their
history of shingles. |
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| Can zoster
vaccine be administered to people in long-term
care facilities? |
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| Yes. RZV can be
administered to anyone age 50 years and older
regardless of where they reside, unless they
have a contraindication to vaccination. |
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| Can I give our
long-term care residents RZV, injectable
influenza, and pneumococcal vaccines on the
same day? |
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| Yes. CDC’s
General Best Practice Guidelines for
Immunization advise that non-live vaccines,
such as RZV, can be administered
concomitantly, at different anatomic
sites, with any other live or non-live
vaccine. They should be given as separate
injections, not combined in the same syringe. |
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| Should
healthcare personnel in long-term care
facilities be tested to see if they have had
chickenpox before taking care of someone who
has received ZVL? |
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| All healthcare
personnel should ensure they are immune to
varicella regardless of the setting in which
they work and regardless of their patients'
receipt of live zoster
vaccine. For healthcare personnel, accepted
evidence of varicella immunity includes any of
the following: 1) documentation of
age-appropriate vaccination with a
varicella vaccine, 2) laboratory evidence of
immunity or laboratory confirmation of
disease; 3) diagnosis or verification of a history of varicella disease by a health-care
provider; or 4) diagnosis or verification of a
history of herpes zoster by a health-care
provider. |
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| The Zostavax
package insert says that clinicians should
consider administering live zoster vaccine and pneumococcal polysaccharide vaccine (PPSV) at
least 4 weeks
apart. What does ACIP say about this? |
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| This wording was
added to the package insert because a Merck
study showed that the varicella antibody titer
in people who received ZVL and PPSV vaccines
at the
same visit were lower than when people
received the vaccines a month apart. However,
there is no known serologic correlate for
protection against shingles so the
importance of this observation is not known.
ACIP has not changed its recommendation on the
simultaneous administration of these two
vaccines. ZVL and PPSV can be
given at the same time or any time before or
after each other. |
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| We know that
documented receipt of ZVL in the absence of
other criteria is not proof of immunity to varicella. Is this true for RZV as well? |
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| Yes. Documented
receipt of RZV cannot be used as proof of
immunity to varicella. Additionally, a dose of
RZV cannot be counted as a dose of varicella
vaccine. Please
note this is different than ZVL. |
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| If a patient
who received live zoster vaccine a week ago
comes in for a tuberculin skin test (TST), do
we need to wait 4 weeks from the time the
patient received the
vaccine before applying the skin test? This is what we currently do with patients who need a TST after receiving MMR vaccine. |
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| Yes. If you have
recently vaccinated the patient with ZVL, you
should delay the TST for 4 weeks from the date
of the vaccine dose. A TST can be applied at
any time
before or after receiving RZV. When TST
screening is needed and ZVL vaccination is
preferred, TST screening should be scheduled
prior to or on the same day as the
ZVL. ACIP's recommendations for use of ZVL do
not address the interval between vaccination
and TST screening. However, ACIP's General
Best Practice Guidelines for
Immunization state that in the absence of
specific recommendations, when scheduling TST
screening and administering other
live-attenuated virus vaccines, clinicians
should follow guidelines for
measles-containing vaccine (please refer to
the General Best Practice Guidelines for
Immunization at
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/special-situations.html). |
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| Can I give a
recombinant zoster vaccine (RZV, Shingrix, GSK)
at the same time as a tuberculin skin test? |
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| Yes. Shingrix is
not a live virus vaccine and does not
interfere with the tuberculin skin test (TST):
it may be administered any time before or
after a TST. Administration of a live virus
vaccine can interfere with a tuberculin skin
test (TST). If the TST is not administered on
the same day as a live virus vaccine, the TST
should be delayed until 4–6 weeks after the
vaccination. |
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What adverse reactions have been reported with
zoster vaccines? |
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| In the
pre-licensure clinical trials of ZVL local
adverse reactions such as pain, redness and
swelling were more common in the vaccinated
group (25%–36%) than in the
placebo group (5%–8%). |
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| In pre-licensure
clinical trials of RZV the most common adverse
reactions were pain at the injection site
(78%), myalgia (45%), and fatigue (45%). Any
grade 3 adverse
event (reactions related to vaccination which
were severe enough to prevent normal
activities) was reported in 17% of vaccine
recipients compared with 3% of placebo
recipients. Grade 3 injection-site reactions
(pain, redness, and swelling) were reported by
9% of vaccine recipients, compared with 0.3%
of placebo recipients. Grade 3
solicited systemic events (myalgia, fatigue, headache, shivering, fever, and
gastrointestinal symptoms) were reported by
11% of vaccine recipients and 2.4% of placebo
recipients. The occurrence of local grade 3
reactions did not differ by vaccine dose.
However systemic grade 3 reactions were
reported more frequently after dose 2. |
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| For both RZV and
ZVL rates of serious adverse events (an
undesirable experience associated with the
vaccine that results in death,
hospitalization, disability or requires
medical or surgical intervention to prevent a
serious outcome) were similar in vaccine and
placebo groups. |
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| What should I
advise my patients about adverse reactions
after RZV? |
|
| Before
vaccination, providers should counsel RZV
recipients about expected systemic and local
adverse reactions (described above). Reactions
to the first dose do not
strongly predict reactions to the second dose.
RZV recipients should be encouraged to
complete the series even if they experienced a
grade 3 reaction to the first dose. |
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| Can the RZV
vaccine (Shingrix) cause shingles? |
|
| No. RZV contains
only a small part of the herpes zoster virus
and does not contain any live herpes zoster
virus. |
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| What are the
contraindications and precautions to zoster
vaccine? |
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| Contraindications
to live zoster vaccine: |
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- Severe allergic reaction to a vaccine
component or following a prior dose
- Immunosuppression from any cause
(disease or treatment of a disease)
- Pregnancy
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| Precautions to
live zoster vaccine: |
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- The presence of a moderate or severe
acute illness. Vaccination should be
deferred until the illness improves
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| Contraindication
to recombinant zoster vaccine: |
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- Severe allergic reaction to a vaccine
component or following a prior dose
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| Precaution to
recombinant zoster vaccine: |
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-
The presence of a moderate or severe
acute illness, including herpes zoster.
Vaccination should be deferred until the
illness improves.
-
There are no available data to establish
whether RZV is safe in pregnant or lactating
women and there is currently no ACIP
recommendation for RZV use in this
population. Consider delaying vaccination
with RZV in such circumstances.
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| If an adult
has had zoster with postherpetic neuralgia or
ophthalmic complications, when can they
receive zoster vaccine? |
|
| Once they are no
longer acutely ill, they can be vaccinated
with RZV or ZVL. There is no evidence that
either vaccine will have therapeutic effect
for a person with
existing zoster or postherpetic neuralgia. |
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| How long
should we wait before giving zoster vaccine to
a patient who has had a blood transfusion? |
|
| There is no
waiting period for administering either zoster
vaccine following transfusion. The amount of
antigen in ZVL is high enough to offset any
effect of antibody to
varicella virus that may be in the blood
product. RZV does not contain live virus so
can be given at any time after receipt of a
blood product. |
|
| Can zoster
vaccine be given to a person who is currently
receiving immunosuppressive treatment? |
|
| ACIP recommends
the use of RZV or ZVL in persons taking
low-dose immunosuppressive therapy (less than
20 mg/day of prednisone or equivalent or using
inhaled or
topical steroids), or low doses of
methotrexate, azathioprine, or
6-mercaptopurine. |
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| As with all live
vaccines ZVL is contraindicated in persons
receiving high-dose steroid therapy, cancer chemotherapy or treatment with immune
modulators (see
www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html).
RZV is currently licensed for all persons 50
years of age and older. Immunosuppression is
not included as a contraindication in the
manufacturers’ package insert.
However, immunocompromised persons and those
on moderate to high doses of immunosuppressive
therapy were excluded from the clinical
efficacy studies so data are
lacking on efficacy and safety in this group.
ACIP has not made a recommendation regarding
the use of RZV in these patients. This topic
is anticipated to be discussed
at upcoming ACIP meetings as additional data
become available. |
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| I have a
patient who is eligible for zoster vaccination
who is going to be receiving chemotherapy
soon. What are the guidelines in such a
situation? |
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| The risk for
zoster and its severe morbidity and mortality
is much greater for immunosuppressed people. A
2-dose series of RZV should be administered as
soon as
possible while the person’s immune system is
intact. If ZVL is preferred the patient should
receive 1 dose as soon as possible, while
their immunity is intact. Administer
ZVL at least 14 days before immunosuppressive
therapy begins. Some experts advise delaying
the start of immunosuppressive therapy until 1
month after ZVL is
administered, if delay is possible.
Anticipated immunosuppression is a comorbid
condition for which ZVL vaccination at age 50
years or older could be considered (see
www.cdc.gov/mmwr/pdf/wk/mm6044.pdf, page
1528). |
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| When can a
patient previously on immunosuppressive
chemotherapy receive zoster vaccine? |
|
| ACIP has not
specifically addressed the use of RZV in this
situation but it is prudent to defer RZV until
the patient’s immune system has recovered from
the treatment. If
the patient was receiving cancer chemotherapy,
wait 3 months after therapy is discontinued
before administering ZVL. If they were
receiving high-dose steroids,
isoantibodies, immune-mediators, or immunomodulators, wait 1 month after therapy
is discontinued to administer ZVL. |
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| A dose of
zoster vaccine was inadvertently given to a
patient receiving chemotherapy for colon
cancer. We realize this was an error, so
please advise us on what to do
now. |
|
| Zoster vaccines
are given to people who presumably had
chickenpox earlier in life and so have
immunity to varicella virus. The cancer
chemotherapy will not change the
person's immunity to varicella virus. If the
person received RZV no action is necessary.
However, if ZVL was given the patient should
be monitored for the next two weeks
for symptoms that might indicate an adverse
reaction, such as fever and rash. If symptoms
suggestive of varicella develop, the patient
can be started on antiviral therapy,
such as acyclovir. |
|
| Can someone
with hepatitis C receive zoster vaccine? |
|
| Hepatitis C
infection is not a contraindication for either
zoster vaccine. However, if someone with
hepatitis C is receiving a medication that can
cause
immunosuppression, they should consult with
their healthcare provider and consider
delaying vaccination with ZVL or RZV until
they have completed treatment. |
|
| Should a
healthy person age 60 years or older receive
live zoster vaccine if they are going to be in
contact with an unvaccinated infant or an
immunocompromised
person? |
|
| Neither situation
is a contraindication to ZVL vaccination. A
person who receives ZVL who has close
household or occupational contact with people
who are at risk for
developing severe varicella or zoster
infection need not take any special
precautions after receiving ZVL vaccine. The
only exception is in the rare instance when a
person develops a varicella-like rash after
receiving ZVL. A vaccine rash is expected to
occur less frequently after ZVL than after
varicella vaccine. If a rash develops, the
vaccinated person should avoid contact with an
immunocompromised person if the
immunocompromised person is susceptible to
varicella. |
|
| The Zostavax (ZVL)
package insert says that the vaccine is
contraindicated in a person with a history of primary or acquired immunodeficiency states,
leukemia,
lymphoma or other malignant neoplasms
affecting the bone marrow or lymphatic system.
Does this mean that a person who was treated
for lymphoma many years ago
and is now healthy should not receive zoster
vaccine? |
|
| No. A person who
was treated for leukemia, lymphoma, or other
malignant cancers in the past and is now
healthy and not receiving immunosuppressive
treatment may
receive ZVL or RZV. However, a person who is immunosuppressed for any reason (disease or
treatment) should not receive ZVL. |
|
| Can a person
age 60 years or older with a diagnosis of an
autoimmune disease, such as lupus or rheumatoid arthritis, receive zoster vaccine? |
|
| RZV can be
administered in this situation. ZVL can also
be administered, with one qualification. A
diagnosis of an autoimmune condition such as
lupus or rheumatoid
arthritis is not a contraindication to ZVL.
However, the treatment of these conditions may
involve the use of an immunosuppressive drug,
which could be a
contraindication. |
|
| A 65-year-old
patient is having major back surgery next
week. He is requesting zoster vaccine today.
Can I give him the vaccine? |
|
| RZV can be
administered in this situation. ZVL can also
be administered with one qualification. There
is no contraindication to vaccinating against
zoster before surgery,
unless the patient is immunocompromised for
some reason. |
|
| We have a
patient with a severe allergy to vancomycin
who wants to receive zoster vaccine. According
to the Zostavax prescribing information, an
allergy to neomycin
would be a contraindication to vaccination but
we are not sure about allergy to vancomycin. |
|
| Vancomycin and
neomycin belong to different classes of
antibiotics. An allergy to vancomycin is not a contraindication to zoster vaccine. RZV does
not contain either
neomycin or vancomycin. |
|
| We have a
61-year-old patient who is taking 500 mg of
valacyclovir (Valtrex) daily. Can she receive
zoster vaccine? |
|
| Acyclovir,
famciclovir, and valacyclovir are antiviral
drugs that are active against herpesviruses.
These drugs' agents might interfere with
replication of live zoster vaccine
(ZVL) but will have no effect on RZV (which
does not contain live varicella virus). All
three drugs have relatively short serum
half-lives and are quickly eliminated from the
body. Persons taking acyclovir, famciclovir,
or valacyclovir should discontinue the drug at
least 24 hours before administration of ZVL,
if possible. The drug should not be
taken again for at least 14 days after ZVL
vaccination, by which time the immunologic
effect of the vaccine should be established. |
|
| If my patient
is taking Tamiflu (oseltamivir), can she
receive zoster vaccine? |
|
| Yes. Although
oseltamivir is an antiviral drug, it is only
effective against influenza A and B viruses.
Live zoster vaccine contains varicella zoster
virus which is not affected
by oseltamivir. RZV does not contain live
virus and also will not be affected by oseltamivir. |
|
| Zoster vaccine
was inadvertently given to a patient taking
Humira (adalimumab) 40 mg per week for rheumatoid arthritis. Because of the high
dose, should the patient be
started on antivirals as prophylaxis or should
the patient just be monitored? |
|
| RZV does not
contain live varicella virus although response
to the vaccine could be reduced in persons who
are immunosuppressed. Although ZVL is
contraindicated for
patients taking biologic agents including
tumor necrosis factor (TNF) antagonists (adalimumab
is a TNF antagonist), vaccinating patients
that are immunocompromised is
unlikely to result in serious adverse events. |
|
| It is prudent to
monitor your patient who received ZVL with a
low threshold for any signs of adverse events
(such as rash or fever), within one month
after vaccination, but
prophylactic antivirals are not indicated.
Acyclovir, valacyclovir, and famciclovir are
active against the vaccine virus and can be
used in the unlikely situation in which
illness develops. |
|
|
|
|
|
| How are zoster
vaccines administered? |
|
| Reconstitute
recombinant zoster vaccine (RZV; Shingrix; GSK)
using only the adjuvant solution provided with
the vaccine antigen. After reconstitution,
administer RZV
immediately by the intramuscular route or
store the reconstituted vaccine refrigerated
between 2° and 8°C (36° and 46°F) and use
within 6 hours. Discard reconstituted
vaccine if not used within 6 hours or if
frozen. If RZV is reconstituted with other
than the supplied adjuvant solution, it should
be repeated. The dose can be repeated
immediately. There is no interval that must be
met between these doses. |
|
| Reconstitute ZVL
using only the diluent provided. Administer
ZVL by the subcutaneous route immediately
after reconstitution to minimize loss of
potency. If the vaccine is
not administered within 30 minutes of
reconstitution it must be discarded. |
|
| The Zostavax
package insert says to inject the vaccine into
the deltoid region of the upper arm. We always give subcutaneous vaccines in the triceps area
of the arm. Is
this wrong? |
|
| No. The
subcutaneous tissue overlying the triceps
muscle of the upper arm is the usual location
for subcutaneous vaccine injection for an
adult. |
|
| A patient was
inadvertently given RZV by the subcutaneous
rather than the intramuscular route. Does the dose need to be repeated? |
|
| RZV has been
shown to be immunogenic when given by the
subcutaneous route. A dose erroneously given
by this route does not need to be repeated. |
|
| When
reconstituted, the volume of ZVL is 0.65 mL.
Should 0.65 mL or 0.5 mL be administered to
the patient? |
|
| The recommended
dose for ZVL is the fully reconstituted
amount, 0.65 mL. |
|
| When
reconstituted, the volume of RZV is more than
0.5 mL. Should the entire volume of
reconstituted vaccine be administered or just
0.5 mL as indicated in the package
insert? |
|
| The RZV adjuvant
solution may contain up to 0.75 mL of liquid.
The entire volume of the adjuvant solution
should be withdrawn and used to reconstitute
the lyophilized
vaccine. After mixing, withdraw the
recommended dose of 0.5 mL. Any reconstituted
vaccine left in the vial should be discarded. |
|
| Can
pharmacists in all states administer zoster
vaccine? |
|
| According to the
American Pharmacist Association, all states
allow pharmacists to administer zoster
vaccine. Not all pharmacists provide
vaccination services, and of
those who do, not all administer zoster
vaccine. It is best to call the pharmacy ahead
of time to find out if they have zoster
vaccine to administer to your patients. The
vaccine must be administered in the pharmacy.
Do NOT instruct the patient to transport the
vaccine from the pharmacy back to your office.
This could damage or
destroy the potency of the vaccine. See below
for more information on this issue. |
|
| If we
inadvertently give a child live zoster vaccine
rather than varicella vaccine, what should we
do? |
|
| This is a serious
vaccine administration error. The event should
be documented and reported to either the
Vaccine Adverse Event Reporting System (VAERS)
or the
manufacturer. Procedures should put in place
to prevent this from happening again. ZVL
contains about 14 times as much varicella
vaccine virus as varicella vaccine.
However, no specific medical action needs to
be taken in response to this vaccine
administration error. If this was the child's
first dose of varicella-containing vaccine
he/she will still need the second dose of
varicella-containing vaccine on schedule. |
|
| A 60-year-old
patient was inadvertently given varicella
vaccine instead of zoster vaccine. Should the patient still be given the zoster vaccine? If
so, how long an interval
should occur between the 2 doses? |
|
| CDC recommends
that if a provider mistakenly administers
varicella vaccine to a person for whom zoster
vaccine is indicated, no specific safety
concerns exist, but the
dose should not be considered valid. RZV
should be administered at least 8 weeks after
receipt of the varicella vaccine. However, if RZV is administered less than 8
weeks after the varicella vaccine, it does not
need to be repeated. A second dose of RZV
should be given 2–6 months after the first
dose of RZV. If the clinician prefers to
use ZVL a dose can be administered at the same
visit. If not given at the same visit ZVL
should be administered at least 4 weeks after
the varicella vaccine dose to
prevent potential interference of 2 doses of
live attenuated virus. Avoid such errors by
checking the vial label 3 times to make sure
you're administering the product you
intended. |
|
| If varicella
vaccine is inadvertently given to an adult to
prevent shingles, the previous recommendation was to give ZVL at same visit or at least 28
days later. Now, with the
preference for RZV, should the recommendation
be to give RZV at least 8 weeks later? |
|
| Yes. If varicella
vaccine is inadvertently given to an adult to
prevent shingles, CDC suggests that RZV be
given at least 8 weeks later. |
|
| If RZV is
erroneously given to a child for prevention of
varicella, the dose is invalid, but is there a
waiting period before a valid dose of
varicella vaccine can be given? Is
it OK to give a dose of varicella vaccine as soon as the error is discovered? |
|
| There is no
waiting period. The varicella vaccine dose can
be given at any time after the RZV dose. |
|
| We
inadvertently gave ZVL rather than RZV. Can
the dose of ZVL be counted as the first dose
of the RZV series? |
|
| No. Doses of ZVL
(Zostavax) cannot be counted towards
completing the RZV (Shingrix) series. In this
case, the first dose of RZV should be given at
least 8 weeks after
the dose of ZVL that was administered. |
|
| We
inadvertently gave a 47-year-old healthcare
worker live zoster vaccine rather than
varicella vaccine for work. Does this dose
count? |
|
| Yes, but this is
a serious vaccine administration error because
ZVL contains about 14 times as much varicella vaccine virus as varicella vaccine. You should
document
the event and report it to either the Vaccine
Adverse Event Reporting System (VAERS) or the
manufacturer. You should establish procedures
to prevent this from
happening again. The dose of ZVL can be
counted as the first of two doses of varicella
vaccine for an adult who is not immune to varicella. The second dose of varicella
vaccine should be given 4 to 8 weeks after the
first dose. |
|
| While giving a
dose of RZV (Shingrix) the syringe came loose
from the needle and part of the dose was lost. Will the patient be protected with this
partial dose or does it
need to be repeated? |
|
| A dose less than
the full 0.5 mL dose is not valid and should
be repeated. If the patient is still in the
office the dose can be repeated immediately.
If the repeat dose
cannot be given on the same day CDC recommends
that it should be given 4 weeks after the
invalid dose. |
|
| My medical
assistant inadvertently administered a 0.5 mL
dose of the RZV (Shingrix) diluent only. The dose did not contain any antigen. When can we
administer a
properly reconstituted dose? |
|
| The CDC zoster
subject matter experts recommend that in this
situation you should wait 4 weeks before
giving a repeat dose. |
|
| Several doses
(antigen and diluent) of RZV were mistakenly
stored in our office freezer. One of these
doses was administered to a patient. Is this
dose valid and if not,
when can it be repeated? |
|
| Any RZV, either
antigen or diluent, that is exposed to
freezing temperature should not be used. If a
dose exposed to freezing temperature is given
to a patient the dose
should be considered invalid and should be
repeated 4 weeks after the invalid dose. |
|
|
|
|
|
| How should
zoster vaccine be stored? |
|
| RZV (Shingrix) |
|
| Both lyophilized
RZV and the adjuvant solution diluent must be
stored at refrigerator temperature, between 2°
and 8°C (between 36° and 46°F). Protect the
vials from
light. Do not freeze. Vaccine or adjuvant
solution that has been frozen must be
discarded. If vaccine that was frozen was
administered, the dose does not count and
should be repeated. The repeat dose should be
administered 4 weeks after the frozen dose. |
|
| After
reconstitution, administer RZV immediately or
store refrigerated between 2° and 8°C (between
36° and 46°F) and use within 6 hours. Discard
reconstituted vaccine
if not used within 6 hours. |
|
| ZVL (Zostavax) |
|
| All vaccines that
contain live varicella virus, including ZVL,
must be stored frozen at a temperature of
between -50°C and -15°C (between -58°F and
+5°F) until they are
reconstituted. Although the manufacturer
states that any freezer that has a separate
sealed freezer door and reliably maintains a
temperature between -50°C and -15°C
is acceptable for storage of
varicella-containing vaccines, CDC recommends
the use of a separate stand-alone freezer to
store frozen vaccines. A storage unit that is
frost-free or has an automatic defrost cycle
is preferred. The diluent should be stored
separately at room temperature or in the
refrigerator. |
|
| ZVL should be
reconstituted immediately upon removal from
the freezer. Administer zoster vaccine
immediately after reconstitution to minimize
loss of potency. Discard
reconstituted vaccine if not used within 30
minutes. Do not freeze reconstituted vaccine. |
|
| If necessary, ZVL
may be stored at refrigerator temperature
between 2°C and 8°C (between 36°F and 46°F)
for up to 72 continuous hours prior to
reconstitution. ZVL
stored between 2°C and 8°C that is not used
within 72 hours of removal from a freezer
should be discarded. |
|
| How should
zoster vaccine be transported to an off-site
clinic location? |
|
| RZV is stored at
refrigerator temperature. Transport of
refrigerated vaccines is described in detail
in the CDC Storage and Handling Toolkit,
available at
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf,
pages 21–24. Providers should also review the
vaccine package inserts for the specific
vaccines being transported. |
|
| Neither CDC nor
the vaccine manufacturer recommends
transporting live varicella-containing
vaccines. If these vaccines must be
transported (for example during an
emergency), CDC recommends transport in a
portable freezer unit that maintains the
temperature between -50°C and -15°C (-58°F and
+5°F). Portable freezers may be
available for rent in some places. If live
varicella-containing vaccines must be
transported and a portable freezer unit is not
available, do NOT use dry ice. Dry ice may
subject varicella-containing vaccines to
temperatures colder than -50°C (-58°F). |
|
| Live
varicella-containing vaccines may be
transported at refrigerator temperature
between 2°C and 8°C (between 36°F and 46°F)
for up to 72 continuous hours prior to
reconstitution. ZVL stored between 2°C and 8°C
(between 36°F and 46°F) that is not used
within 72 hours of removal from a freezer
should be discarded. Instructions for
transporting vaccines are available in the CDC
Storage and Handling Toolkit at
www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf,
pages 21–24.
Providers should also review the vaccine
package inserts. |
ACIP Recommendations
Vaccine Information Statements 
